skin lesions wart-like spots
Conditions
Interventions
Each patient will receive up to two topical administrations of BL-5010 to one
SK lesion. The investigator will apply a titrated dose of BL 5010 to the one
SK lesion.
Sponsors
BioLineRx Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients will be included in the study if they: 1. Are male or post menopausal female Caucasian patients between 18 to 85 years of age who can provide and have signed a written informed consent, and understand and comply with the requirements of the protocol 2. Have at least one SK lesion on the face (except for the first ten patients), scalp (only lesions that are not located within the hairline), trunk, or extremities that is 2.5 to 5 mm at its widest diameter and is not near the eye, nose, or mouth (e.g., investigator judges that the distance between the index lesion and either the eye, nose, or mouth is far enough to prevent BL 5010 causing irritation
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they have or meet any of the following criteria: 1. Have no individual SK lesions >2.5 mm that are not separated by at least 2 cm 2. Have no individual SK lesion but have only *collision lesions* 3. Have a history of keloid formation following surgical removal of skin lesions or other forms of dermal injury 4. Have any type of infection (e.g., methicillin-resistant staphylococcus aureus infection, etc.) 5. Are immunocomprised including all transplant patients or patients receiving any chemotherapy 6. Have a known diagnosis of Hepatitis B or C, or HIV 7. Have clinically significant unstable medical problems such as diabetes mellitus, clinically concerning cardiac arrhythmias, arteriosclerotic heart disease, renal insufficiency or failure, history of malignant melanoma, or history of cancer (excluding basal cell carcinoma) within the past 5 years prior to Screening 8. Have a clinically significant laboratory test in the 30-day interval prior to Screening such as a hemoglobin level below 10 gm/dL or an AST or ALT level greater than three times the upper limit of normal, etc. 9. Have been hospitalized for any medical condition within one month prior to Screening 10. Have used illicit drugs of abuse or have a history of alcohol abuse in the 3-month interval prior to Screening 11. Have been exposed to an investigational drug or device within 30 days prior to Screening or is scheduled to receive another investigational drug or device during either the Treatment Phase or Follow-up Evaluation 12. Have taken within the past 6 months or are currently taking any immunomodulatory drugs (e.g., ciclosporine, tacrolimus, etc.), biologic drugs (e.g., infliximab, Enbrel, etc.), or immunosuppressive drugs (e.g., azathioprine, corticosteroids, etc.) unless they have consented to an acceptable washout as follows: • Systemic treatments (steroids, immune suppressants, etc.) - 1 month washout • Exposure to ultra-violet light - 1 month washout • Topical treatments (topical steroids, etc.) - 2 week washout 13. Are fertile men who are not willing to use an acceptable form of contraception. Where male patients have a female partner of childbearing potential, the female partner should use two different but effective forms of contraception.;Acceptable forms of effective contraception include: • a. Established use of oral, injected or implanted hormonal methods of contraception • b. Placement of an intrauterine device (IUD) or intrauterine system (IUS) • c. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository • d. Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate) • e. True abstinence: When this is in line with the preferred and usual lifestyle of the patient;Males should use a barrier method during and for 3 months after their last dose of study drug, unless they are sterilized, in which case a period of 7 days can be applied.;For inclusion into the study female patients must: • be postmenopausal for at least 1 year, OR • have had a bilateral oopherectomy and/or hysterectomy, OR • have had a bilateral tubal ligation or otherwise be incapable of pregnancy;The following lesions cannot be used as the *index lesion*: 1. Actinic keratosis, warts, condylomata acuminatum, or mo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess whether BL-5010 is safe for use in patients with seborrheic keratosis (SK) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess whether BL-5010 induces dermal irritation at the site of the application of BL-5010 To determine whether BL-5010 completely removes the SK index lesion after one or two applications of BL-5010 To assess the cosmetic outcome as assessed by the investigator and the patient at the site of the sloughed-off index lesion To determine the feasibility of histological examinations of the sloughed-off index lesion | — |
Countries
Netherlands
Outcome results
None listed